The strategic investment supports the growing demand for development and commercial phase production of viral-vector based therapies.
The new site, scheduled to be operational in early 2019, will be built at Novasep’s facility in Seneffe, Belgium, to complement the existing lab-scale suites of the neighboring site in Gosselies.
The site will feature two cGMP suites on 2000 sqm. equipped with a set of single-use bioreactors ranging from 200L up to 2000L. It will fit perfectly with the production requirements for phase III and commercial stages.
“Many types of viral vectors are currently being developed, making each project specific. The team in Belgium is recognized worldwide for its outstanding expertise in viral vector production on almost all kinds of expression systems“, said Novasep Chairman and CEO, Dr. Michel Spagnol. “We are proud to see that our US and European customers are eager to pursue the development of their products with us by actively supporting this investment.”
The plant is a response to the strong market demand driven by both a growing interest in this therapeutic approach and a maturing clinical pipeline. The viral vectors are used in gene therapies or immunotherapies such as new cancer treatment strategies and in “new generation” therapeutic vaccines. With more than 300 products in clinical studies and 9 products launched, the market is expecting to see high single-digit growth over the five next years.
The therapeutic approach consists in using the ability of a virus to introduce the genetic material into the host cell. With viral vectors, the genetic material is modified in order to repair the host cell. Typical viral vectors are Lentiviruses, Adenoviruses, and Adeno-associated viruses.
“These innovative therapies require targeted technologies for their production, and as a leading CMO, we strive to constantly adapt our team expertise to fulfil our customer’s expectations” added Spagnol. “This investment is the new jewel of the set of facilities we have been investing in over the past 5 years and I am confident it will contribute to fuel Novasep’s growth.“
